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临床试验/CTRI/2025/02/080389
CTRI/2025/02/080389尚未招募不适用

Comparing HACOR (Heart rate, Acidosis, Consciousness, Oxygenation, Respiratory rate) score and ROX (Respiratory rate Oxygenation) index as a predictor of non invasive ventilation failure in acute hypoxemic patients.

Anush Gowda A S1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年3月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
To compare the HACOR [heart rate, acidosis (arterial pH), consciousness (Glasgow Coma Scale), oxygenation, and respiratory rate] score and ROX (Respiratory rate Oxygenation) index in predicting non invasive ventilation (NIV) failure.

研究概览

简要总结

This study is a prospective observational study that aims to compare the HACOR (Heart rate, Acidosis, Consciousness, Oxygenation, Respiratory rate) Score and the ROX (Respiratory rate–Oxygenation) Index in predicting the failure of non-invasive ventilation (NIV) in patients with acute hypoxemia in around 100 patients. The patients will be selected based on the inclusion criteria and consecutive sampling method. The patients who are undergoing non invasive ventilation (NIV) will be assessed for NIV status before initiating the NIV, after 2 hours and 12 hours of initiation using HACOR and ROX index. The primary outcome is to compare the HACOR score and ROX index in predicting non invasive ventilation failure. The secondary outcome will be the duration of invasive mechanical ventilation, duration of ICU stay, and 28 day mortality. The final results will be interpreted using ROC (Receiver Operating Characteristic) analysis, comparing the AUC (Area Under The Curve) for both score. The score which has higher AUC indicates a better predictive ability for the outcome.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Use of non invasive ventilation via oronasal mask.

排除标准

  • Patients aged above 80 years.
  • Use of HFNC before NIV.
  • Rescue and prophylactic use of non invasive ventilation after extubation.
  • Chest trauma.
  • Obstetric patients.

结局指标

主要结局

To compare the HACOR [heart rate, acidosis (arterial pH), consciousness (Glasgow Coma Scale), oxygenation, and respiratory rate] score and ROX (Respiratory rate Oxygenation) index in predicting non invasive ventilation (NIV) failure.

时间窗: The outcome will be assessed at before initiating the non invasive ventilation (NIV), after 2 hours, and after 12 hours of initiation.

次要结局

  • Duration of invasive mechanical ventilation, duration of ICU stay, & 28 day mortality.(Mortality will be assessed exactly 28 days after NIV initiation.)

研究者

发起方
Anush Gowda A S
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Anush Gowda A S

Kasturba Medical College, Mangalore

研究点 (1)

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